gammaCore Sapphire D

Primary DI

00815203020447

Brand

gammaCore Sapphire D

Company

electroCore, Inc.

Model

11016-40303

Catalog number

11016-40303

Device description

gammaCore Sapphire D is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude. It includes a charging station incorporated into the “clam shell” storage case connected to a power adapter to charge the device as necessary by the end user. Catalog Number 11016-40303 is programmed to deliver 24 doses per day for 12 months (1 year). Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period. A manufacturer accessible only Bluetooth feature is enabled to facilitate device diagnostics of any devices returned to the manufacturer to allow a review of the number of days the device was used, number of doses provided, and any days / doses yet remaining on a device.

Published

2020-05-22

Public version status

Update

Distribution status

In Commercial Distribution

MRI safety

MR Unsafe

Rx

true